NCT01104350已完成1 期
Phase I Dose-Escalation Study of Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 5
- 主要终点
- To determine the dose limiting toxicity and establish the maximal tolerated dose
研究概览
简要总结
The purpose of this study is to test the safety of different amounts (doses) of external radiation therapy (high-energy x-rays that shrink or destroy cancer) combined with chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MSKCC-reviewed pathologically proven diagnosis of primary bladder urothelial carcinoma without evidence of regional (nodal) or distant spread (cT1-T4a, Nx or N0).
- •Karnofsky Performance Scale (KPS) ≥ 70%
- •Age ≥18 years old
- •Adequately functioning bladder, defined as continent and without the need for an indwelling catheter
- •Absolute neutrophil count (ANC) ≥ 1500/mL; platelets ≥ 100,000/mm3 serum bilirubin < 1.5 x the upper limit of normal (ULN); aspartate aminotransferase (AST) and/alanine aminotransferase (ALT) ≤ 1.5 × ULN
- •Adequate renal function: calculated creatinine clearance > 30 mL/min/1.73 m2 using the following formula modified Cockcroft and Gault Formula for estimated Creatinine Clearance
- •Patients must be considered able to tolerate systemic chemotherapy and pelvic radiation therapy.
- •Patients must have the ability to understand and the willingness to sign a written informed consent document
排除标准
- •Evidence of distant disease or histologically-proven nodal metastases. Patients with radiologic evidence of lymphadenopathy must have biopsy proof of N0 status.
- •Previous pelvic radiation therapy
- •Prior systemic chemotherapy non-cisplatin based neoadjuvant for urothelial carcinoma (prior intravesical chemotherapy or immunotherapy is permissible)
- •Prior cisplatin based neoadjuvant systemic chemotherapy for more than >4 cycles
- •Active inflammatory bowel disease (i.e., Crohn's disease or ulcerative colitis)
- •Women who are pregnant or lactating
研究组 & 干预措施
Radiotherapy and Concurrent Gemcitabine Chemotherapy
Experimental
This is a Phase I dose-escalation study examining the safety and tolerability of intensity modulated external radiation therapy using image-guidance in combination with gemcitabine chemotherapy as an alternative to radical cystectomy.
干预措施: external radiation therapy with gemcitabine (Other)
结局指标
主要结局
To determine the dose limiting toxicity and establish the maximal tolerated dose
时间窗: 2 years
次要结局
- To determine the complete response rate of the primary tumor(4-6 weeks following consolidation therapy)
- To determine the long term toxicity(2 years)
研究者
研究点 (5)
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